Inclusion criteria
The inclusion criteria will be the same as those for the feasibility study. The only exception now is that we will only include sedentary participants, as the feasibility study showed they benefited most from the program. Therefore, the inclusion criteria are: (1) time since stroke less than six months (2) ≥ 18 years of age; (3) able to walk ten meters independently at a speed ≥ 0.8 m/s without any walking devices; [
9] (4) no cognitive impairments (determined by the cut-off scores on the Brazilian version of the Mini-Mental State Examination); [
10] (5) sedentary (mean of steps counts < 5,000 steps/day [
11], over four days, determined by a triaxial accelerometer—Actigraph wGT3X-BT, Pensacola, FL, USA). The exclusion criteria are (1) other neurological diseases; (2) comprehensive aphasia (evaluated by simple motor command); [
12] (3) any other conditions that would prevent participation (e.g., recent post-surgery or surgery scheduled, travel or further compromise that prevents the participant from staying in Belo Horizonte during the intervention period).
Randomisation
A computer-generated random allocation sequence will be used. Randomisation will be used to ensure balance (half in the experimental, half in the control). Index cards sequentially numbered according to the random assignment will be printed, folded, and placed in sealed opaque envelopes. A therapist, blinded to baseline measurements, will open the envelope, assign the participant to the corresponding study group, and book the first treatment session. Then, the therapist will deliver the intervention to the experimental group and the education session to the control group. Due to the characteristics of the intervention, it will not be possible to blind the therapist and participants to group allocation.
Intervention – experimental group
A home-based self-management program based on behaviour change techniques will be implemented through the Social-Cognitive Theory [
14] and Control Theory approaches [
15]. According to these theories, a behaviour to achieve a goal is influenced by self-efficacy [
14] and feedback [
15]. In the present study, we will use the Behaviour Change Technique Taxonomy (v1) proposed by Michie et al. 2013 to standardise the way to report
behaviour change techniques [
16]. The intervention protocol was adapted from Preston et al. 2017 and will include six sessions of home-based self-management, with an average duration of sixty minutes [
17]. The content, materials, and theoretical framework of each session are described in Table
2.
Table 2
Intervention components, materials, theoretical framework and behaviour change techniques
Session 1 | Education about stroke (what is, symptoms, risk factors, how to prevent another event) | Booklet “Had a stroke, what now?” | |
Session 2 | Feedback about initial measurement outcomes | Data from Actigraph (steps taken per day) | Feedback on behaviour (CT) |
Education about the consequences of physical inactivity | Booklet “Consequences of physical inactivity” | Health consequences (SCogT) |
Choose a target exercise | Exercise Preference Questionnaire | Action planning (SCogT) |
Generate a list of goals | Goal Attainment Scaling | Graded tasks (SCogT) |
Delivery self-monitoring devices | Smartband and paper-based exercise diary | Self-monitoring of behavior (CT) |
Session 3 | Review goals | Goal Attainment Scaling | Review behavior goal(s) (CT) |
Review strategies to self-monitoring | Smartband and paper-based exercise diary | Self-monitoring of behavior (CT) |
Encouraging | Verbal therapist encouragement | Non-specific encouragement (SCogT) |
Identify barriers and potential solutions | Exercise Benefits/Barriers Scale and paper-based barriers and solutions list | Problem-solving/coping planning (SCogT) |
Implementation of the physical exercise session with the participant | Paper-exercise guide | Instruction on how to perform a behaviour (SCogT) |
Development of a weekly schedule of physical exercise | Weekly activities calendar | Goal setting (behavior) (CT) |
Session 4 | Review goals | Goal Attainment Scaling | Review behavior goal(s) (CT) |
Review strategies to self-monitoring | Smartband and paper-based exercise diary | Self-monitoring of behavior (CT) |
Review weekly schedule physical exercise; | Weekly activities calendar | Goal setting (behavior) (CT) |
Encouraging | Verbal therapist encouragement | Non-specific encouragement (SCogT) |
Review barriers and potential solutions | Paper-based barriers and solutions list | Problem-solving/coping planning (SCogT) |
Vicarious experience | Paper-based stroke survivors report about the self-management program (data from feasibility study) | Vicarious reinforcement (CT) |
Sessions 5 and 6 | Review goals | Goal Attainment Scaling | Review behavior goal(s) (CT) |
Review strategies to self-monitoring | Smartband and paper-based exercise diary | Self-monitoring of behavior (CT) |
Review weekly schedule physical exercise | Weekly activities calendar | Goal setting (behavior) (CT) |
Encouraging | Verbal therapist encouragement | Non-specific encouragement (SCogT) |
Review barriers and potential solutions | Paper-based barriers and solutions list | Problem-solving/coping planning (SCogT) |
Session 1 will include education about stroke (what it is, symptoms, risk factors, how to prevent another event, and orientation regarding the importance of practising physical activity after a stroke).
In Session 2, the therapist will provide feedback about sedentary behaviour and the consequences of physical inactivity. Then, the participants will choose a target exercise through the Exercise Preference Questionnaire [
18] and generate a list of goals using the Goal Attainment Scale (GAS) [
19]. They will be asked to set short, medium and long-term goals using the GAS. In the first moment, participants will be encouraged to set short-term goals that are important to them and with low difficulty levels. As soon as short-term goals are achieved, they will be encouraged to attain medium-term goals (medium difficulty levels). Finally, long-term goals (high difficulty levels) will be added when the medium-term goals are achieved. At the end of the session, self-monitoring devices will be provided to participants. The focus is to show participants that they can perform a behaviour and to help them achieve it by increasing self-efficacy [
14] and providing them with support and feedback [
15].
In Session 3, besides reviewing goals and self-monitoring strategies, the therapist will also verbally encourage all participants to motivate them to achieve a target behaviour. For those participants who completed the target behaviours, the therapist will say, “
You are doing well; let’s move on!”. For those who have not achieved the behaviour, the therapist will say, “
Don’t give up; what can be changed for you to achieve this behaviour?”. Then, barriers to exercise will be assessed by self-reporting and completing the Exercise Benefits/Barriers Scale [
20]. The therapist, the family, and the caregivers will help each participant find solutions to the identified barriers. At the end of the session, the therapist will implement the first physical exercise session with the participant. In addition, a weekly schedule of physical exercise will be developed.
In Session 4, goals, self-monitoring strategies, and weekly physical exercise schedule will be reviewed. Barriers and potential solutions will be discussed, and verbal encouragement will be given as in the previous session. In addition, the therapist will provide a vicarious experience and show participants a paper-based report from the stroke survivors about the self-management program carried out in the previous feasibility study. This report will provide information on the barriers and benefits of this self-management program.
Sessions 5–6 will give the exact content of Session 4 except for vicarious experience.
The home-based self-management program will be delivered individually, in person, at the participant’s home, by a trained physical therapist (with knowledge of behaviour change techniques) over 11 weeks. The six sessions will be scheduled under the availability of the therapist and the participant’s schedule. The first three sessions will have a one-week interval between them. The following two sessions will occur at two-week intervals. Finally, the last visit will appear after a four-week break. Although the program has a standardised structure, some components of the intervention, such as choosing a target exercise, a list of goals in the GAS format, a paper guide to exercise, and a weekly physical exercise schedule, will be developed according to each participant. After exercise, participants will be asked to report any adverse events (falls, pain, etc.). To improve the recording of exercise over the feasibility study, self-monitoring devices (smartband and paper-based exercise diary) will be delivered to participants in Session 2 and will stay with them until Session 6.
Adherence to the home-based self-management exercise program will be measured by Section B of the Exercise Adherence Rating Scale [
21,
22] collected at Week 11. The scores in this section range from 0 to 24; the higher the score, the higher the adherence. The answers to this scale will be based on participant self-report, reading both the smartband records and completing a paper-based exercise diary. To check adherence after the intervention, the therapist will also apply the Exercise Adherence Rating Scale at Week 24.
Control group
The control group will receive one session of education about stroke (what it is, symptoms, risk factors, how to prevent another event, and orientation regarding the importance of practising physical activity after a stroke). This session will occur in the participant’s home, in person, on week 1, by the same therapist who will provide the intervention in the experimental group. In the subsequent weeks, they will receive usual care, which may include medical follow-up and guidance from other healthcare professionals (who are not involved with the research team) regarding the significance of behaviour change after stroke. It is a pragmatic study, so participants of both experimental and control groups will be allowed to perform daily living and healthcare activities (e.g., physiotherapy, occupational therapy, activities in a health centre, etc.).